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Regulatory Agenda European Union Healthcare

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

A&O Shearman

European Health Data Space Regulation sets requirements for electronic health record systems

A&O Shearman on

On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more

Mayer Brown

Europe Daily News, 19 March 2025

Mayer Brown on

COMPETITION - Judgment of the Court of 19 March 2025 in Case T-142/23, Ivo Swenters Vs. European Commission Re: Competition - Agreements, decisions and concerted practices - Abuse of a dominant position - Market for the...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 2, January 2025

Welcome to our second issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the effect of the decline of DEI on the healthcare industry, the fate of Medicaid under the...more

A&O Shearman

Council of the EU adopts the European Health Data Space Regulation

A&O Shearman on

On January 21 2025, the Council of the European Union (Council) announced its decision to adopt the Regulation of the European Parliament and of the Council on the European Health Data Space (EHDS). As we have previously...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

McDermott Will & Schulte

Private Markets Update | Summer 2024

McDermott Will & Schulte on

The Private Markets Update highlights key developments emerging from private markets across Europe, the UK and the United States, exploring the cross-border issues that matter to investors and sponsors in alternative assets. ...more

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

McDermott Will & Schulte

International News: Spotlight on Innovation - Issue 60

Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including: - The EU’s new Unified Patent Court...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

McDermott Will & Schulte

International News: Spotlight on Foreign Investment

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In this dynamic global landscape, investors have always been required to make savvy, smart choices. This requires navigating through the intricate web of bilateral treaty protection, exploring the vital role these agreements...more

McDermott Will & Schulte

Health Data in the EU and UK – Regulatory Trends and Developments

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

Hogan Lovells

Post-registration changes in case of no-deal Brexit

Hogan Lovells on

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more

Bilzin Sumberg

Alphabet Soup and Data Security

Bilzin Sumberg on

In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more

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